Medical Policy: 05.01.33
Original Effective Date: March 2011
Reviewed: January 2016
Benefit determinations are based on the applicable contract language in effect at the time the
services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary
based on contract, and individual member benefits must be verified. Wellmark determines medical
necessity only if the benefit exists and no contract exclusions are applicable. This medical
policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document
was developed. Since that time, new technology may have emerged or new medical literature may
have been published. This Medical Policy will be reviewed regularly and be updated as scientific
and medical literature becomes available.
EGRIFTA™ is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy by once daily self-administered subcutaneous injection. This drug was studied in two double blinded, multicenter, randomized placebo-controlled trials that showed a decrease in abdominal fat, but the effects were modest and not sustained upon discontinuation of the drug. EGRIFTA™ also poses serious potential safety concerns such as increased risk of malignancies and diabetes, which need to be further investigated. The European AIDS Clinical Society Guidelines concluded that pharmacological options for the management of lipodystrophy have not proven long-term effects and may cause new complications for patients.
Non-pharmacological options for treating excess abdominal fat in HIV-infected patients with lipodystrophy include diet/exercise modification and surgical removal. These options are comparably safer and more likely to produce sustainable results.
The use of injectable tesamorelin (EGRIFTA ™) is considered not medically necessary for all applications because it lacks sustainable clinical efficacy and the potential risks do not outweigh the potential benefits.
Procedure Codes and Billing Guidelines:
- To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
- J3490 unclassified drug
- European AIDS Clinical SocietyExternal Site Guidelines for Prevention and Management of Non-Infectious Co-Morbidities in HIV.
- Egrifta. (2010, September). [package insert]. Rockland, MA, USA: Theratechnologies Inc.
- Falutz, J., Alias, S., Blot, K., Potvin, D., Kotler, D., Somero, M., et al. (2007). Metabolic Effects of a Growth Hormone Releasing Factor in Patients with HIV. New England Journal of Medicine , 357, 2359-70.
- Falutz, J., Potvin, D., Mamputu, J.-C., Assaad, H., Zoltowska, M., Michaud, S.-E., et al. (2010). Effect of Tesamorelin, a Growth Hormone-Releasing Factor, in HIV-Infected Patients with Abdominal Fat Accumulation: A Randomized Placebo-Controlled Trial with a Safety Extension. Journal of Acquired Immune Deficiency Syndrome , 53, 311-322.
- Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescentsExternal Site. (2009, December 1) Department of Health and Human Services.
January 2016 - Annual Review, Policy Renewed
February 2015 - Annual Review, Policy Renewed
March 2014 - Annual Review, Policy Renewed
March 2013 - Annual Review, Policy Renewed
February 2012 - Annual Review, Policy Renewed
March 2011 - Annual Review, Policy Renewed
Wellmark medical policies address the complex issue
of technology assessment of new and emerging treatments, devices,
drugs, etc. They are developed to
assist in administering plan benefits and constitute neither offers of
coverage nor medical advice. Wellmark medical policies contain only a
partial, general description of plan or program benefits and do not
constitute a contract. Wellmark does not provide health care services
and, therefore, cannot guarantee any results or outcomes.
Participating providers are independent contractors in private
practice and are neither employees nor agents of Wellmark or its
affiliates. Treating providers are solely responsible for medical
advice and treatment of members. Our medical policies may be updated
and therefore are subject to change without notice.
*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.